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Oci-16g(32)
EUDAMEDClass IIa (EU MDR)
Ref 06937909306619Model OCI-14GRef OCI-16G
Identity
- Trade Name
- OCI-16G(32) EUDAMEDOCI EUDAMED
- Device Name
- Arteriovenous Fistula Needle Sets EUDAMED
- Model / Reference
- OCI-14G EUDAMED06937909306619 EUDAMEDOCI-16G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937909306619 EUDAMED
- Basic UDI-DI
- 69379093AFNS001U6 EUDAMEDB-06937909306619 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDGreece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oci-16g(32) by Chengdu Oci Medical Devices Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69379093AFNS001U6 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69379093AFNS001U6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chengdu Oci Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000009700
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (2)
- EUDAMED 6cb336bc-354c-4c8b-85b7-a9bfb9d3d43e 61 fields · synced Jun 18, 2026
- EUDAMED 0fdab2ff-dede-4881-ad0a-60d2594531da 61 fields · synced Jun 18, 2026